Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture

NCT01647230 | Unknown DMC

• 1 other identifier: 2011612CSPT
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to observe how the hemodynamic changes induced by spinal blockade affect cerebral oxygenation. Elderly patients are very frail. Hypotension is very frequent during spinal anaesthesia. Bradycardia is other side effect of regional anaesthesia affecting cardiac output and cerebral blood flow. These complications of spinal anaesthesia could decline cognitive function. In this way a non invasive monitoring technique as cerebral oximetry is useful for the safety of anesthetic procedure.

Conditions

Femoral Fracture; Blood Pressure; Cognitive Impairment

Keywords

Anaesthesia, spinal; Cerebral oximetry; Blood pressure; Heart rate; Cognitive Symptom

Outcome Measures

Primary Outcomes (4)

• Cerebral Oximetry

  Changes in cerebral oxymetry measured initially (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured evey 10 minutes to obtain the mean of all the values.

  Initial, 3 times after spinal block and every 10 minutes during surgery

• Mean Arterial Pressure (MAP)

  Changes in MAP measured initially (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured every 10 minutes to obtain the mean of all the values

  Initial, 3 times after spinal block and every 10 minutes during surgery

• Heart Rate (HR)

  Changes in HR (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured every 10 minutes to obtain the mean of all the values.

  Initial, 3 times after spinal block and every 10 minutes during surgery

• Oxygen arterial saturation (OSat)

  Changes in OSat measured initially (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured every 10 minutes to obtain the mean of all the values.

  Initial, 3 times after spinal block and every 10 minutes during surgery

Secondary Outcomes (1)

• Short Portable Mental Status Questionnaire (SPMSQ)

  Once before surgery and at 5th postoperative day

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged \> 70 years old with hip fracture undergoing surgery under spinal anaesthesia.

You may qualify if:

• Patients aged \>70 years old with hip fracture.
• No contraindication for spinal anaesthesia.

You may not qualify if:

• Allergic reaction to local anesthetics.
• Severe aortic stenosis.
• Local infection.
• SPMSQ test \>7 errors.
• Patient refusal

Sponsors & Collaborators

• Hospital de Sabadell: lead

Study Sites (1)

Hospital de Sabadell - CSPT

Barcelona, Sabadell, 08208, Spain

RECRUITING

MeSH Terms

Conditions

Femoral Fractures; Cognitive Dysfunction; Neurobehavioral Manifestations

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Diana L Fernández Galinski, PhD

  Hospital de Sabadell - CSPT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana L Fernández Galinski, PhD

CONTACT

0034937231010; DFernandez@tauli.cat

Francisca Gordo Lacal, Dr

CONTACT

0034937231010; fgordo@tauli.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 23, 2012
• Study Start: February 1, 2012
• Study Completion: February 1, 2013
• Last Updated: July 25, 2012

Record last verified: 2012-07

Locations

ES (1)